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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2007 - May 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
none

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gerome (Quartier Labaste - F40260 Linxe)
- Age at study initiation:
- Weight during the test: the animals weighed between 2.46 kg and 2.87 kg.
- Housing: in an individual box
- Acclimation period: 5-days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 18°C and 21 °C
- Humidity (%): between 40% and 68%
- Air changes (per hr): conventional air conditioned

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g of the test item
Observation period (in vivo):
Ocular examinations were performedd on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
If no reaction is observed 72 hours after instillation, the study is terminated.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test item remove with isotonic sodium chloride

SCORING SYSTEM:
CHEMOSIS (A)
• No swelling................................... ............ ....................................................................... .............. 0
• Slight swelling, including the nictitating membrane ...................................................................... 1
• Swelling with eversion ofthe eyelid............................................................................ .................. 2
• Swelling with eyelid half-closed...................................................................................... ........... ... 3
• Swelling with eyelid more than half-closed .................................................................... .... ........... 4

DISCHARGE (B)
• No discharge .................................................. ..................... .. ... ...................................................... 0
• Slight discharge (normal slight secrelions in the inner corner not to be
taken into account)....................................................................................................................... .. 1
• Discharge with moistening ofthe eyelids and neighbouring hairs ........ ............................ ............. 2
• Discharge with moistening of the eyelids and large areas around the eye ..................................... 3

REDNESS (C)
• Blood vessels normal. .................................................................................................................... 0
• Vessels significantly more prominent than normal........................................................................ 1
• Vessels individuaIly distinguishable with difficulty
Generalised red coloration........................................................................... ........ ..................... 2
Generalised deep red coloration .................................................. ................. ..... ................ .... ... 3

IRIS (D)
• Normal................... ................................................................................................................ ........ 0
• Iris significantly more wrinkled than normal, congeslion,
swelling ofthe iris which continues to react to light, even slowly................................................. 1
• No reaction to light, haemorrhage, significant damage
(any or all ofthese characteristics) ................................................................................................ 2

CORNEA: DEGREE OF OPACITY (E)
• No modification visible either directly or after
instillation of fluorescein (no 1055 of glint or polish) ...................... .......... ..................................... 0
• Translucent areas (diffuse or disseminated), iris details clearly visible .......... ............ .... ............... 1
• Easily identifiable translucent area, iris details slightly obscured.................................................. 2
• Opalescent area, no iris details visible, pupil outline scarcely distinguishable .............................. 3
• Total comeal opacity, completely obscuring the iris and pupil.............................................. ........ 4

CORNEA: EXTENT OF OPACITY (F)
• Opaque area present but covering one quarter or less .................................................................... 1
• Between one quarter and half.. ....................................................................................................... 2
• Between half and three quarters .. ......................................................... .......................................... 3
• Between three quarters and the entire surface.................................. .............................................. 4


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
CHEMOSIS
Basis:
animal: #1,#2,#3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
REDNESS
Basis:
animal: #1,#2,#3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
iris score
Remarks:
LESION
Basis:
animal: #1,#2,#3
Time point:
other: 24.48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Remarks:
OPACITY
Basis:
animal: #1,#2,#3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
DISCHARGE
Basis:
animal: #1,#2,#3
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
REDNESS
Basis:
animal: #1,#2,#3
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
CHEMOSIS
Basis:
animal: #2, #3
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
- Raw data for each individual animal at each observation time up to removal of each animal from the test: data are given in above block of fields
'Irritation / corrosion results'.
Other effects:
none

Any other information on results incl. tables

The ocular conjunctivae reactions observed during the study have been slight and rapidly reversible in the three animals: a slight redness was noted only 1 hour after the test item instillation associated a slight chemosis in two animals only 1 hour after the test item instillation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not to be classified
Executive summary:

The test item was instilled as supplied, at the dose of 0.1 g, into the eye of one New Zealand rabbit (n=3).

The ocular conjunetivae reactions observed during the study have been slight and rapidly reversible in the three animals: a slight redness was noted only 1 hour after the test item instillation assoeiated a slight chemosis in !wo animals only 1 hour after the test item instillation.